FLOW CANNULA M with fixing for HFNC

Organization name

GINEVRI srl

SRN

IT-MF-000034527

Manufacturer status

Active

Certificate health across this manufacturer's portfolio.

3 warnings recorded — scroll inside the panel to see all entries.

• CW009

  EUDAMED did not publish a description for this code.
• CW020

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Italy; available across 32 countries total.

Trade name

FLOW CANNULA M with fixing for HFNC

UDI-DI code

08053847360396

Basic UDI-DI

80538473617SR

Reference / catalog number

13606L73

Issuing entity

GS1

Risk category

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

The FLOW CANNULA with fixing for HFNC is applied to the newborn by inserting the cannula into the orifices of the nose to administer respiratory gases and promotes non-invasive ventilation by promoting gas exchange without causing special damage to the ventilated lung. In the newborn, artificial ventilation is usually a temporary action to support lung function until complete spontaneous ventilatory autonomy is achieved. Its goals are: - Provide adequate alveolar ventilation with CO2 removal and satisfactory oxygenation; - Reduce respiratory work. Recent guidelines and studies demonstrate the importance of non-invasive ventilation. Product intended for use on premature infants and newborns requiring supplemental oxygen, respiratory support or assistance in breathing in ambulatory and hospital settings. It is used for the following therapies: Non-invasive, heated or unheated, humidified flow ventilation (HFNC)

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

• Medium

European Medical Device Nomenclature — the EU product classification assigned to this device.

• V0502CLINICAL ADMINISTRATION KITS NOT INCLUDED IN OTHER CLASSES